Efficacy, Effectiveness, and Safety of Ustekinumab for the Treatment of Ulcerative Colitis: A Systematic Review.

OBJECTIVE: This study aimed to evaluate ustekinumab efficacy, effectiveness, and safety as a treatment for ulcerative colitis in adult patients. METHODS: A systematic review of the efficacy, effectiveness, and safety of ustekinumab in ulcerative colitis was carried out. The search was conducted via PubMed, Embase, and the Cochrane library. Two reviewers independently assessed the quality of studies and extracted study data. RESULTS: Of the 892 studies identified, 17 were included: 1 randomized controlled trial (RCT), 3 long-term extensions, and 13 observational studies. In the randomized clinical trial evaluating efficacy at week 8, clinical remission was achieved in 16% of patients, whereas clinical response was achieved in 51% and 62% of patients who received intravenous ustekinumab at a dose of 130 mg and 6 mg/kg, respectively. At 3 years' follow-up, symptomatic remission was achieved in 68% of patients. On the other hand, the effectiveness of ustekinumab was evaluated in 13 observational studies. In these studies, clinical remission at induction was achieved in 24% to 61% of cases, whereas clinical response at induction was achieved in 47% to 77% of cases. Moreover, clinical remission was achieved in 33% to 79% of cases at 52 weeks of follow-up. The adverse events ranged from 2.6% to 77% of all the studies that reported safety data. Adverse events leading to discontinuation ranged from 2.6% to 8.1%, and serious adverse events were uncommon and ranged from 3.7% to 6.0%. CONCLUSIONS: Ustekinumab has demonstrated efficacy (in RCTs), effectiveness (in real clinical practice), and safety for the treatment of ulcerative colitis.

This systematic review concluded that for the treatment of ulcerative colitis, ustekinumab has not only demonstrated efficacy in randomized controlled trials (and their extension studies) but also effectiveness and safety in observational studies from real clinical practice.

Modeling the potential efficiency of a blood biomarker-based tool to guide pre-hospital thrombolytic therapy in stroke patients.

OBJECTIVES: Stroke treatment with intravenous tissue-type plasminogen activator (tPA) is effective and efficient, but as its benefits are highly time dependent, it is essential to treat the patient promptly after symptom onset. This study evaluates the cost-effectiveness of a blood biomarker test to differentiate ischemic and hemorrhagic stroke to guide pre-hospital treatment with tPA in patients with suspected stroke, compared with standard hospital management. The standard care for patients suffering stroke consists mainly in diagnosis, treatment, hospitalization and monitoring. METHODS: A Markov model was built with four health states according to the modified Rankin scale, in adult patients with suspected moderate to severe stroke (NIHSS 4-22) within 4.5 hours after symptom onset. A Spanish Health System perspective was used. The time horizon was 15 years. Quality-adjusted life-years (QALYs) and life-years gained (LYGs) were used as a measure of effectiveness. Short- and long-term direct health costs were included. Costs were expressed in Euros (2022). A discount rate of 3% was used. Probabilistic sensitivity analysis and several one-way sensitivity analyses were conducted. RESULTS: The use of a blood-test biomarker compared with standard care was associated with more QALYs (4.87 vs. 4.77), more LYGs (7.18 vs. 7.07), and greater costs (12,807€ vs. 12,713€). The ICER was 881€/QALY. Probabilistic sensitivity analysis showed that the biomarker test was cost-effective in 82% of iterations using a threshold of 24,000€/QALY. CONCLUSIONS: The use of a blood biomarker test to guide pre-hospital thrombolysis is cost-effective compared with standard hospital care in patients with ischemic stroke.

Cost-Effectiveness Analysis of Pertuzumab Plus Trastuzumab and Docetaxel Compared With Trastuzumab and Docetaxel in the Adjuvant Treatment of Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer in Colombia.

OBJECTIVES: The addition of pertuzumab to the scheme of docetaxel plus trastuzumab (TH) in patients with metastatic breast cancer with overexpression of human epidermal growth factor receptor 2 increases survival. Nevertheless, this addition could represent a high cost for the health system of a middle-income country such as Colombia. Therefore, it is necessary to evaluate the efficiency of the pertuzumab plus TH (PTH) scheme in comparison with TH. METHODS: A partitioned survival model-based cost-utility analysis was performed. Progression-free survival and overall survival curves for each scheme were obtained from the CLEOPATRA study. The time horizon was 30 years with a discount rate of 5% for costs and quality-adjusted life-years. Total direct costs were calculated using national tariffs. Utilities were obtained from external sources. Model uncertainty was evaluated by deterministic and probabilistic sensitivity analysis. A willingness to pay value of 5180 US dollars was used. RESULTS: The discounted total average costs of TH and PTH were $24 109 and $60 846, respectively. These regimens' average life-years were 5.78 and 8.38, and their quality-adjusted life-years were 3.28 and 4.51, respectively. The incremental cost-effectiveness ratio was $29 867. One-way sensitivity analysis showed that the cost of pertuzumab was the variable that explained the uncertainty in the model. The probability that PTH is cost-effective in the probabilistic sensitivity analysis is 0.0724. CONCLUSIONS: The addition of pertuzumab to the TH regimen in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer has a low probability of being cost-effective from the payer's perspective in the Colombian health system.

Assessment of the efficacy of a Crisis Intervention Team (CIT): experience in the Esplugues Mental Health Center (Barcelona).

AIM: Crisis Resolution Teams (CRT) have shown positive clinical and service-use results in various countries but evidence in the south of Europe is scarce. The aim is to assess the impact of the Crisis Intervention Team (CIT) in Spain with respect to the course of symptomatology and mental health services use in patients served. METHODS: Prospective observational cohort study. Assessment of the psychopathological severity (HoNOS scale) of the clinical course (CGI scale) and use of medical services. RESULTS: A positive clinical course was observed following the intervention. The mean difference in HoNOS (Health of the Nation Outcome Scales) scores between baseline and discharge was 7 points (p < 0.05). On discharge, more than 60% of patients had improved their symptomatology according to the CGI scale (Clinical Global Impression) and most were discharged due to improvement or goal achievement. A tendency to reduction in the number of admissions to acute units and day hospital was observed, along with fewer emergency room visits. In contrast, an increase in the number of admissions to subacute units was seen. During the intervention, the median number of visits to the center was 15 and the median duration of care provision by the CIT was 39 days. CONCLUSIONS: The CIT intervention promotes patients' clinical improvement and has a positive impact in terms of reducing acute hospitalizations and emergency room visits.

Pediatric Medication Noninitiation in Spain.

OBJECTIVES: To estimate medication noninitiation prevalence in the pediatric population and identify the explanatory factors underlying this behavior. METHODS: Observational study of patients (<18 years old) receiving at least 1 new prescription (28 pharmaceutical subgroups; July 2017 to June 2018) in Catalonia, Spain. A prescription was considered new when there was no prescription for the same pharmaceutical subgroup in the previous 6 months. Noninitiation occurred when a prescription was not filled within 1 month or 6 months (sensitivity analysis). Prevalence was estimated as the proportion of total prescriptions not initiated. To identify explanatory factors, a multivariable multilevel logistic regression model was used, and adjusted odds ratios were reported. RESULTS: Overall, 1 539 003 new prescriptions were issued to 715 895 children. The overall prevalence of 1-month noninitiation was 9.0% (ranging from 2.6% [oral antibiotics] to 21.5% [proton pump inhibitors]), and the prevalence of 6-month noninitiation was 8.5%. Noninitiation was higher in the youngest and oldest population groups, in children from families with a 0% copayment rate (vulnerable populations) and those with conditions from external causes. Out-of-pocket costs of drugs increased the odds of noninitiation. The odds of noninitiation were lower when the prescription was issued by a pediatrician (compared with a primary or secondary care clinician). CONCLUSIONS: The prevalence of noninitiation of medical treatments in pediatrics is high and varies according to patients' ages and medical groups. Results suggest that there are inequities in access to pharmacologic treatments in this population that must be taken into account by health care planners and providers.

Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).

BACKGROUND: Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS: An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS: The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION: The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION: Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.

Cost-effectiveness analysis of nonoperative management versus open and laparoscopic surgery for uncomplicated acute appendicitis in Colombia.

BACKGROUND: Traditionally, uncomplicated acute appendicitis (AA) has been treated with appendectomy. However, the surgical alternatives might carry out significant complications, impaired quality of life, and higher costs than nonoperative treatment. Consequently, it is necessary to evaluate the different therapeutic alternatives' cost-effectiveness in patients diagnosed with uncomplicated appendicitis. METHODS: We performed a model-based cost-effectiveness analysis comparing nonoperative management (NOM) with open appendectomy (OA) and laparoscopic appendectomy (LA) in patients otherwise healthy adults aged 18-60 years with a diagnosis of uncomplicated AA from the payer´s perspective at the secondary and tertiary health care level. The time horizon was 5 years. A discount rate of 5% was applied to both costs and outcomes. The health outcomes were quality-adjusted life years (QALYs). Costs were identified, quantified, and valorized from a payer perspective; therefore, only direct health costs were included. An incremental analysis was estimated to determine the incremental cost-effectiveness ratio (ICER). In addition, the net monetary benefit (NMB) was calculated for each alternative using a willingness to pay lower than one gross domestic product. A deterministic and probabilistic sensitivity analysis was performed. METHODS: We performed a model-based cost-effectiveness analysis comparing nonoperative management (NOM) with open appendectomy (OA) and laparoscopic appendectomy (LA) in patients otherwise healthy adults aged 18-60 years with a diagnosis of uncomplicated AA from the payer's perspective at the secondary and tertiary health care level. The time horizon was five years. A discount rate of 5% was applied to both costs and outcomes. The health outcomes were quality-adjusted life years (QALYs). Costs were identified, quantified, and valorized from a payer perspective; therefore, only direct health costs were included. An incremental analysis was estimated to determine the incremental cost-effectiveness ratio (ICER). In addition, the net monetary benefit (NMB) was calculated for each alternative using a willingness to pay lower than one gross domestic product. A deterministic and probabilistic sensitivity analysis was performed. RESULTS: LA presents a lower cost ($363 ± 35) than OA ($384 ± 41) and NOM ($392 ± 44). NOM exhibited higher QALYs (3.3332 ± 0.0276) in contrast with LA (3.3310 ± 0.057) and OA (3.3261 ± 0.0707). LA dominated the OA. The ICER between LA and NOM was $24,000/QALY. LA has a 52% probability of generating the highest NMB versus its counterparts, followed by NOM (30%) and OA (18%). There is a probability of 0.69 that laparoscopy generates more significant benefit than medical management. The mean value of that incremental NMB would be $93.7 per patient. CONCLUSIONS: LA is a cost-effectiveness alternative in the management of patients with uncomplicated AA. Besides, LA has a high probability of producing more significant monetary benefits than NOM and OA from the payer's perspective in the Colombian health system.

Cost-Effectiveness of the Addition of Bevacizumab to First-Line Chemotherapy With Carboplatin and Paclitaxel in Patients With Non-Small Cell Lung Cancer.

OBJECTIVES: To evaluate the incremental cost-effectiveness ratio (ICER) of the addition of bevacizumab to first-line chemotherapy with carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC) from the perspective of the Colombian health system. METHODS: A Markov model was employed to evaluate the cost-effectiveness of bevacizumab + carboplatin + paclitaxel (BCP) compared with carboplatin + paclitaxel (CP) in the treatment of NSCLS during a 4-year period. The health outcome was the number of life-years gained (LYG) and quality-adjusted life-years (QALYs) obtained from the survival curves reported in a clinical study. Costs were estimated using national tariff and reported in US dollars at a date in 2019. Costs and effectiveness outcomes were discounted at a rate of 3.5% per year. A probabilistic sensitivity analysis was performed on important parameters with a Monte Carlo simulation. RESULTS: The costs of BCP and CP were $30 341 and $11 735, respectively. The LYG for BCP and CP were 0.34 and 0.29, respectively. The QALY for BCP and CP were 0.27 and 0.23. The ICER of BCP versus CP was $ 465 150 QALY. The results of the Monte Carlo simulation showed that CP was cost-effective in 100% of the iterations compared with BCP. CONCLUSION: The addition of bevacizumab to the scheme carboplatin + paclitaxel compared to carboplatin + paclitaxel for NSCLC is not cost-effective from the point of view of the Colombian health system.

Economic Evaluations Informed Exclusively by Real World Data: A Systematic Review.

Economic evaluations using Real World Data (RWD) has been increasing in the very recent years, however, this source of information has several advantages and limitations. The aim of this review was to assess the quality of full economic evaluations (EE) developed using RWD. A systematic review was carried out through articles from the following databases: PubMed, Embase, Web of Science and Centre for Reviews and Dissemination. Included were studies that employed RWD for both costs and effectiveness. Methodological quality of the studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Of the 14,011 studies identified, 93 were included. Roughly half of the studies were carried out in a hospital setting. The most frequently assessed illnesses were neoplasms while the most evaluated interventions were pharmacological. The main source of costs and effects of RWD were information systems. The most frequent clinical outcome was survival. Some 47% of studies met at least 80% of CHEERS criteria. Studies were conducted with samples of 100-1000 patients or more, were randomized, and those that reported bias controls were those that fulfilled most CHEERS criteria. In conclusion, fewer than half the studies met 80% of the CHEERS checklist criteria.

Prevalencia y factores asociados a la adherencia terapéutica en pacientes de un programa integral de crónicos en un centro de atención primaria de Cali: comparación de diferentes test de adherencia / Prevalence and factors associated with therapeutic non-adherence in primary health care of Cali: comparison of three adherence tests

Introducción: La no adherencia terapéutica en pacientes crónicos con riesgo cardiovascular representa un importante problema de salud pública y está relacionado con aumento en la morbilidad y costos en salud. Objetivo: Identificar la prevalencia y los factores asociados a la no adherencia terapéutica a través de diferentes test en los pacientes en el programa de Unidad Prestadora Integral Crónico en atención primaria en salud. Metodología: Se incluyó pacientes que tenían hipertensión arterial, diabetes mellitus y/o dislipidemia, que tuvieran medicamentos prescritos. Se valoró la adherencia farmacológica a través de los test de Haynes- Sackett, Morisky- Green y Batalla. La adherencia no farmacológica se realizó a través de un cuestionario ad-hoc. Se incluyó variables sociodemográficas, patologías, medicamentos prescritos y estilos de vida del paciente. Se realizó análisis estadístico descriptivo y de regresión logística con análisis bivariado y multivariado con el programa STATA(R) 13. Resultados: Se incluyó 85 pacientes, 68% mujeres, la edad media fue de 59 años. El 91% de los pacientes eran adherentes según el test de Haynes-Sackett, 20% por el test de Morisky-Green y un 64% por el test de Batalla. La adherencia no farmacológica fue del 59%. La edad, y estar jubilado estuvo asociado a la adherencia terapéutica. Conclusión: La adherencia terapéutica varió desde un 20%na un 91% dependiendo del test empleado. Se identificó asociación de la adherencia con las variables edad y ocupación

Introduction: Non-adherence in chronic patients with cardiovascular risk represents a public health problem and it is related to an increase in morbidity and health costs. Objectives: To identify the prevalence and factors associated with therapeutic non-adherence through different test in patients from the program "Unidad Prestadora Integral Crónico" in primary health care. Methods: Patients who had high blood pressure, diabetes mellitus and / or dyslipidemia and had been prescribed with some medications were included. The medication adherence assessment was done through the Haynes-Sackett, Morisky-Green and Batalla tests. The non-pharmacological adherence was carried out through an ad-hoc questionnaire. Sociodemographic variables, diseases, prescribed medications and patient's lifestyle were included. A statistical descriptive and logistic regression analysis was performed with bivariate and multivariate analysis with the STATA(R) 13 program. Results: The study included 85 patients, 68 % women; the average age was 59 years. 91 % of the patients were adherent according to the Haynes-Sackett test, 20 % by the Morisky-Green test and 64 % by the Batalla test. The non-pharmacological adherence was 59 %. The age and the fact of being retired was associated with therapeutic adherence. Conclusion: Therapeutic adherence ranged from 20 % to 91 % depending on the test. It was identified the association of adherence the variables of age and occupation

Cost-Effectiveness of Combination Therapy Versus Monotherapy in Benign Prostatic Hyperplasia: A Colombian Experience.

OBJECTIVES: To estimate the incremental cost-effectiveness ratio of pharmacological treatment for benign prostatic hyperplasia from the payer's perspective. METHODS: The cost-effectiveness of 5 mg finasteride, 0.5 mg dutasteride, 10 mg alfuzosin, 10 mg terazosin, 0.4 mg tamsulosin, 4 mg doxazosin, and the combination therapy of 5 mg finasteride and 8 mg doxazosin was evaluated using a Markov model over a 30-year period. The costs were estimated using national tariffs and were reported in US dollars. Cost and effectiveness outcomes were discounted at a rate of 5% per year. Men (aged ≥40 years) with moderate to severe lower urinary tract symptoms and uncomplicated benign prostatic hyperplasia were included in the analysis. Outcomes included costs and quality-adjusted life-years. A probabilistic sensitivity analysis was performed on important parameters with Monte-Carlo simulation. RESULTS: Finasteride alone or in combination with doxazosin dominated all α-blockers. After excluding dominated alternatives, the incremental cost-utility ratio for combination therapy was $377 per quality-adjusted life-year, being a cost-effective alternative using the threshold of $15 000. Model results were robust to changes in costs, utility weights, and probabilities. Acceptability curves consistently demonstrated that the combination therapy was most likely cost-effective. CONCLUSIONS: The combination of finasteride and doxazosin is cost-effective compared with dutasteride, tamsulosin, terazosin, and alfuzosin in patients with benign prostatic hyperplasia with moderate or severe symptoms who are older than 40 years.

Resultados negativos de la medicación en el servicio de urgencias de un hospital, Cali, Colombia / Evaluatrion of negative outcomes associated with medication in an emergency service of a hospital, Cali, Colombia: Cross-sectional study

Introducción: La amplia utilización de medicamentos, los problemas de salud que pueden aparecer asociados a los mismos y la escasez de datos con respecto a esta problemática en Colombia, motivaron a realizar este estudio. Objetivo: Proponer estrategias de intervención para prevenir y/o resolver Resultados Negativos de la Medicación (RNM) en pacientes que presentaron enfermedades de base: diabetes, hipertensión y Enfermedad Pulmonar Obstructiva Crónica en el servicio de urgencias de la Clínica Amiga de Cali. Métodos: Estudio transversal, en el que se revisó las historias clínicas y entrevistó a los pacientes que cumplían con los criterios de inclusión, con el fin de evaluar la necesidad, efectividad y seguridad de los medicamentos a través de la metodología SOAP y poder así realizar intervenciones farmacéuticas. Los resultados fueron analizados estadísticamente. Resultados: 26 pacientes presentaron RNM, el 41,2% fueron de seguridad, el 38,3% de necesidad y el 20,6% de efectividad; las principales causas fueron problemas de salud no tratados y la falta de cumplimiento terapéutico. Ser mujer, tener 65 años o más, y ser no cumplidor al tratamiento farmacológico, es un factor de riesgo ante los RNM, no obstante, no se observó significancia estadística. Las intervenciones farmacéuticas fueron educar y monitorizar al paciente, añadir un medicamento y modificar la dosis del fármaco. Conclusión: El 35,6% de los pacientes presentaron por lo menos un RNM, mayoritariamente de seguridad no cuantitativa. Se realizó intervención farmacéutica a cada uno delos RNM y al cumplimiento terapéutico

Background: The widespread use of drugs, the health problems that can appear associated with them and the lack of data regarding this problematic issue in Colombia, motivate to carry out this project. Objective: To evaluate the presence of negative outcomes associated with medication (NOM) in patients that have underlying diseases such as diabetes, hypertension and chronic obstructive pulmonary disease in the Emergency Department at Clinic Amiga in Cali, and to propose intervention strategies in the identified NOM. Methods: It was carried out a cross-sectional study in which the medical records were reviewed and, the patients that met the inclusion criteria, were interviewed in order to assess the needs, effectiveness and safety of medicines through the SOAP methodology and so being able to carry out pharmaceutical interventions. Demographic and clinical variables, presence of NOM and type of intervention proposed were included. A descriptive and association analysis was done. Results: 26 patients presented NOM, 41.2% were of safety, 38.3% of necessity and 20.6% of effectiveness. The main causes were untreated health problems and lack of therapeutic compliance. Being a woman, being 65 years or older, and being noncompliant to pharmacological treatment, is a risk factor for NOM. However, no statistical significance was observed. The pharmaceutical interventions were related to educate and monitor the patient, add a drug and modify the dose of the drug. Conclusion: 35.6% of the patients presented, at least, one NOM, mainly linked to non-quantitative safety. Pharmaceutical intervention was performed on each of the NOM and in the therapeutic compliance

Resultados negativos asociados a la medicación en pacientes con artritis reumatoide en tratamiento con medicamentos biotecnológicos en un centro de atención primaria en Cali, Colombia / Negative outcomes related to medication, based on the use of biotechnological drugs in patients with rheumatoid arthritits in a primary care center of Cali, Colombia

Introducción: La artritis reumatoide es una enfermedad inflamatoria crónica que afecta negativamente la calidad de vida, cuyo tratamiento se basa en fármacos modificadores de la enfermedad sintéticos o biotecnológicos. Objetivo: Plantear estrategias de intervención farmacéutica en pacientes con artritis reumatoide en tratamiento con medicamentos biotecnológicos. Métodología: Se realizó un estudio de carácter prospectivo en un centro de atención primaria, empleando una adaptación del método Dáder de seguimiento farmacoterapéutico para la identificación de resultados negativos de la medicación (RNM) y posterior planteamiento de las intervenciones. Se valoró el cumplimiento terapéutico. Resultados: Se incluyeron 40 pacientes, de los cuales el 55% se encontraba en tratamiento con etanercept, 30% con tocilizumab, 7,5% con infliximab, 5% con adalimumab y 2,5% con certolizumab pegol. Se detectaron 16 RNM en 12 pacientes, el 50% fueron de efectividad, el 43,75% de seguridad y el 6,25% de necesidad. El 75% de los RNM se encontraban asociados a los medicamentos biotecnológicos. Se determinó un nivel de adherencia farmacológica del 85%. Se realizó intervención farmacéutica a los RNM identificados y al cumplimiento terapéutico. Pacientes con Disease Activity Score (DAS) 28>3,2 mostraron más riesgo de presentar RNM. Conclusión: Se detectaron 16 RNM mayoritariamente por el uso de biotecnológicos, los principales RNM fueron de inefectividad e inseguridad no cuantitativa. Hubo asociación estadísticamente significativa entre una actividad media o alta de la enfermedad y la presencia de RNM

Introduction: Rheumatoid arthritis is a chronic inflammatory disease that negatively affects the quality of life and whose treatment is based on synthetic or biotechnological drugs which modify the disease. Objective: To propose strategies of pharmaceutical intervention in patients with rheumatoid arthritis in treatment with biotechnological drugs. Methodology: A prospective study was carried out in a primary care center, using an adaptation of the Dáder method of pharmacotherapeutic follow-up for the identification of negative outcomes associated with medication (NOM) and subsequent planning of the interventions. The therapeutic compliance was assessed. Results: 40 patients were included in the study, among which 55% were in treatment with etanercept, 30% with tocilizumab, 7.5% with infliximab, 5% with adalimumab and 2.5% with certolizumab pegol. Sixteen NOMs were detected in 12 patients, 50% were related to effectiveness, 43.75% to safety and 6.25% to indication. 75% of the NOMs were associated with biotechnological drugs. A level of 85% of pharmacological adherence was determined. Pharmaceutical intervention was carried out in the identified NOMs and also in the therapeutic compliance. Patients with Disease Activity Score (DAS) 28> 3.2 faced higher risk of developing NOM. Conclusion: 16 NOMs were detected. They were mainly caused by the use of biotechnology. The most important NRM were related to ineffectiveness and non quantitative insecurity. There was a statistically significant association between a medium or high activity of the disease and the presence of NOMs